Entolimod

Ticker Symbol to Change from TIVC to VBIO Effective April 28, 2026; Company Advancing Entolimod™ Toward BARDA Funding and Strategic National Stockpile Procurement While Velocity Bioworks CDMO Builds Independent Revenue Base SAN ANTONIO, April 23, 2026 /PRNewswire/ -- Tivic Health Systems, Inc. (Nasdaq: TIVC) today announced it is changing its corporate name to Valion Bio, Inc. and its Nasdaq ticker symbol from TIVC to VBIO, effective at market open on Tuesday, April 28, 2026. The CUSIP number for the company's common stock will remain unchanged. The rebrand is not merely cosmetic. It reflects the completion of a fundamental strategic transformation — the deliberate unwinding of a consumer medical device business and its replacement with a focused late-stage biopharmaceutical platform anchored by a government-priority asset with over 15 years and more than $140 million in cumulative development investment, and supported by a wholly owned biomanufacturing subsidiary. A Differentiated Asset at the Intersection of National Preparedness and Oncology Valion Bio's lead drug candidate, Entolimod™, is a novel Toll-like receptor 5 (TLR5) agonist with a differentiated, dual-utility profile. As a medical countermeasure for Acute Radiation Syndrome (ARS), Entolimod has received FDA Fast Track and Orphan Drug designations and is being advanced under the FDA's Animal Rule pathway — a regulatory framework that enables approval based on animal efficacy data when human trials are not feasible or ethical, substantially reducing clinical execution risk. The company is actively engaged with BARDA, DTRA, NIAID, and allied government agencies regarding Entolimod's inclusion in the U.S. Strategic National Stockpile (SNS), where a procurement contract — if secured — would represent a non-dilutive, potentially nine-figure revenue event. Critically, Entolimod's mechanism — cytoprotection of bone marrow and gastrointestinal epithelial tissue through NF-κB signaling — positions it for parallel development in oncology supportive care. The global neutropenia treatment market exceeds $22 billion and is projected to approach $30 billion by the early 2030s. Valion Bio is targeting physician-sponsored clinical trials in chemotherapy-induced neutropenia in 2026, with Phase IIb readiness as the objective. Entolasta™, a next-generation TLR5 agonist, provides additional pipeline depth and intellectual property extension across both indications. "The Valion Bio name reflects the company we have become. We have a late-stage asset with validated biology, regulatory designations, a clear government procurement pathway, and a world-class manufacturing operation under one roof. This is a different company than the one that existed 18 months ago — and the new name should make that unmistakable to every investor, partner, and government stakeholder we engage." — Michael K. Handley, Chief Executive Officer, Valion Bio Handley, who previously served as CEO of Statera Biopharma, where he led the advancement of Entolimod, brings direct institutional knowledge of the asset, its regulatory history, and its government agency relationships. His appointment as CEO of Valion Bio in March 2026 consolidated scientific, commercial, and operational leadership of the program under a single decision-maker with a proven track record in biologic drug development at scale. Velocity Bioworks: Manufacturing as a Strategic and Financial Asset Valion Bio's wholly owned CDMO subsidiary, Velocity Bioworks, was acquired in December 2025 for approximately $16.3 million and represents a core pillar of the company's strategy — not a peripheral asset. Velocity Bioworks provides the company with domestic, controlled manufacturing capability for Entolimod, enabling supply chain security that is increasingly a prerequisite for government procurement partnerships. The subsidiary also recently completed a 200-fold manufacturing scale-up of Entolimod using 50-liter fermentation — on time, within budget, and meeting all purity and potency specifications. Beyond its internal role, Velocity Bioworks operates as a standalone CDMO with the ability to serve third-party early-stage biotech clients, targeting the historically underserved Phase I and Phase II biologics manufacturing gap. At full utilization, management believes Velocity Bioworks has the potential to evolve into a self-sustaining, cash flow-positive operation — providing the company a path to non-dilutive commercial revenue independent of the drug development timeline. Strategic Positioning and Macro Tailwinds Valion Bio is deliberately headquartered in San Antonio, Texas — proximity to the DoD biodefense ecosystem, including Brooke Army Medical Center, is not coincidental. The company's ARS countermeasure program sits at the intersection of several converging macro forces: a renewed federal focus on domestic biomanufacturing, accelerating global demand for national preparedness infrastructure following heightened nuclear threat awareness, and a bipartisan mandate to rebuild and modernize the Strategic National Stockpile. Allied government agencies are independently evaluating Entolimod for their own national stockpiling programs, creating a potential multi-jurisdictional procurement opportunity. About Valion Bio (Tivic Health Systems, Inc.) Valion Bio is a late-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and immune modulation. The company's lead candidate, Entolimod™, is a TLR5 agonist with over 15 years of development history, FDA Fast Track and Orphan Drug designations, and active engagement with U.S. government agencies for potential Strategic National Stockpile inclusion. The company also advances Entolasta™, a next-generation TLR5 agonist, and targets the neutropenia oncology supportive care market. Velocity Bioworks, Valion Bio's wholly owned CDMO subsidiary, supports internal manufacturing and services third-party biotech clients. For more information, visit Forward-Looking Statements This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim, "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Valion Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod™; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; changes to the company's business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Valion Bio's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, under the heading "Risk Factors", as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law. Investor Contact [email protected] SOURCE Tivic Health Systems, Inc. 21% more press release views with Request a Demo

SAN ANTONIO, April 15, 2026 /PRNewswire/ -- Tivic Health Systems, Inc. (Nasdaq: TIVC), a clinical-stage immunotherapeutics company, today announced it has been selected to present at the U.S. Department of War's Tech Watch program on May 7, 2026. The Tech Watch initiative identifies emerging technologies with high-value defense and dual-use applications. Tivic Health will present its Entolimod™ TLR5 agonist lead drug candidate and its plans for an oral transmucosal delivery program for Entolimod™ — a delivery concept the Company believes has compelling and immediate relevance for both individual warfighter care and large-scale mass casualty response. The Company is currently in the process of engaging a specialized formulation development partner to advance this program. "The geopolitical environment has fundamentally changed the calculus around medical countermeasure preparedness," said Michael K. Handley, chief executive officer of Tivic Health Systems. "The threats are no longer theoretical — governments around the world are actively reassessing their readiness, and the window to establish Entolimod™ as a cornerstone of national and allied defense stockpiles has never been more open. We believe this is the right technology, at exactly the right time." Entolimod™ is a selective Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from radiation-induced damage across both bone marrow and gastrointestinal tissues simultaneously. This dual-system mechanism represents a meaningful advance over currently stockpiled ARS countermeasures, including Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which are designed to stimulate hematopoietic recovery but do not address the lethal damage caused to the gastrointestinal tract at higher radiation doses — a key determinant of survival that remains a significant unmet need. The Company is in early-stage exploration of an oral transmucosal delivery formulation intended to extend this radioprotection advantage by making Entolimod™ faster to administer, more stable, and accessible in scenarios where intravenous or injectable delivery is not practical. If successfully developed, an oral transmucosal formulation could be administered rapidly, without needles, and without the need for trained medical personnel — a critical advantage in combat environments and mass casualty events where speed of treatment and ease of administration can determine survival outcomes. The Company believes this delivery approach, if realized, could meaningfully expand access to life-saving countermeasures in scenarios where conventional medical infrastructure is unavailable, overwhelmed, or destroyed. "Our Entolimod™ platform was built to address the most urgent unmet needs in radiation medicine, and we believe an oral transmucosal approach, if successfully developed, would take that mission to the next level," Mr. Handley continued. "For the warfighter in the field and for first responders managing a mass casualty event, the ability to administer an effective radiation countermeasure quickly, simply, and without specialized equipment would be transformative. We look forward to presenting this vision to the Department of War on May 7th and to advancing what we believe is a critical component of national preparedness." The Department of War has expressed encouraging interest in advancing discussions with Tivic Health regarding Entolimod™ and its potential applications for national defense preparedness. Strategic and Competitive Positioning Warfighter relevance: Addresses a critical unmet need in military radiation casualty care with a mechanism that protects both GI and hematopoietic tissues Mass casualty potential: Early-stage oral transmucosal delivery concept, if developed, could enable rapid treatment of large numbers of casualties without trained personnel or medical infrastructure Differentiated mechanism: Dual GI and bone marrow protection versus currently stockpiled G-CSF therapies, which address only hematopoietic recovery Administration simplicity (target profile): No needle, no IV, no specialized equipment required — subject to successful formulation development Regulatory pathway: Advancing toward BLA submission under the FDA's Animal Rule About Tivic Health Systems Tivic Health is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The company's lead candidate, Entolimod™ for acute radiation syndrome (ARS), has been extensively studied having demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule. Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod™ for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Tivic is also advancing Entolasta™, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Tivic's clinical pipeline includes potential treatments for neutropenia, which is most commonly caused by chemotherapy, and a state of T-cell dysfunction known as lymphocyte exhaustion. Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development manufacturing organization (CDMO) offering biomanufacturing services to third-party biotech companies. Tivic also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes and supply chain security. For more information, visit . Forward-Looking Statements This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod™; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; expectations regarding the potential benefits of the leadership transition; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; the ability to successfully engage a formulation development partner and develop an oral transmucosal delivery formulation; changes to the company's business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC, under the heading "Risk Factors", as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law. Investor Contact: Tivic Investor Relations [email protected] Media Contact: DJ Freyman [email protected] SOURCE Tivic Health Systems, Inc. 21% more press release views with Request a Demo